PAIN RELIEF ROLL ON  EVORA LABS- lidocaine liquid 
Evora Worldwide

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pain Releif Lidocaine 4%

Active ingredient                                               Purpose


Lidocaine 4%..................................................... Topical analgesic

Uses

For temporary relief of pain and itching

Warnings


For externa use only.


When using this product • use only as directed • do not bandage tightly • avoid contact with
eyes  • do not apply to wounds or  damaged skin • do not use in large quantities, particularly over raw  surface or blistered areas.

Stop use and ask doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days


Flammable • keep away from fire or flame


If pregnant or breast-feeding, ask a health professional before
use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
• Children under 2 years old: consult a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
ALOE VERA LEAF
AMINOMETHYLPROPANOL 
Caprylyl Methicone
CETOSTEARYL ALCOHOL
CETETH-20 PHOSPHATE
DIHEXADECYL PHOSPHATE 
DIMETHICONE 
EDETATE DISODIUM
Ethylhexylglycerin 
GLYCERYL STEARATE
METHYLPARABEN 
SD ALCOHOL 40
STEARETH-21 
WATER

Questions?

1-888-793-8450

image description

PAIN RELIEF ROLL ON   EVORA LABS
lidocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77375-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALCOHOL (UNII: 3K9958V90M)  
STEARETH-21 (UNII: 53J3F32P58)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77375-007-021 in 1 CARTON12/22/2020
174 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/22/2020
Labeler - Evora Worldwide (081336028)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(77375-007)

Revised: 1/2022
Document Id: d58d704a-bbe3-2335-e053-2a95a90aeed7
Set id: 6694758f-4d71-4ca4-b1c2-dace8871bf6c
Version: 3
Effective Time: 20220114
 
Evora Worldwide